分析および生物分析技術ジャーナル

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A Concise Study of Organic Volatile Impurities in Ten Different Marketed Formulations by [GC/HS-FID/MS] Gas Chromatography Technique

Gnana Raja M, Geetha G and Sankaranarayanan A

Organic solvents such as Methanol, Isopropyl alcohol and Dichloromethane frequently used in sustained release or controlled release dosage form in pharmaceutical industry for coating. The good choice of solvent for coating of modified release dosage form is Methanol, Isopropyl alcohol and Dichloromethane. A selective Gas Chromatographic GC/HS-FID method has been developed and validated as per ICH guidelines for residual solvent quantification and confirmed the mass number by GC/HS-MS method. The separation was carried out on DB 624 column (30 m, 0.53 mm, [ID] 0.25 mm coating thickness), using Perkin Elmer/Clarus 500 GC/MS, with nitrogen as carrier gas in the split mode by head space injection method. The method described is simple, sensitive, rugged, reliable and reproducible for the quantization of Isopropyl alcohol, methanol and Dichloromethane at residual level in marketed modified release dosage form. In this paper completely demonstrated the method of quantification of residual solvents by GC/HS/FID and confirming by GC/HS/MS of the residual solvents present in 10 different marketed products availed in southern part of India. The enteric coated product has been selected and experiment was performed.